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临床试验/CTIS2022-502176-23-01
CTIS2022-502176-23-01招募中1 期

A multicentre, triple blind, placebo controlled, parallel group study of atorvastatin in episodic migraine (StatinMigEpisodic) - StatinMigEpisodic

St. Olavs Hospital HF0 个研究点目标入组 450 人开始时间: 2023年3月22日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
450

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 64(—)
性别
All

入选标准

  • Aged 18 to 65 years with 4-14 migraine days per month, Signed informed consent, Episodic migraine with or without aura according to ICHD-3 criteria, debut of migraine at least one year prior to inclusion, and start of migraine before age 50 years, No use of other migraine prophylactics during the study, For women of child-bearing potential there must be no pregnancy or planned pregnancy during the study period, and use of highly effective contraception

排除标准

  • Interval headache not distinguishable from migraine or chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on = 15 days/month., Pregnancy, planning to get pregnant, inability to use contraceptives or lactating., Clinical information on signs of cholestasis, decreased hepatic or renal function, high degree of comorbidity, frailty associated with reduced life expectancy, high likelihood of hospitalization at the discretion of the investigator,, history of angioneurotic oedema, current use of antiviral treatment against hepatitis C, significant psychiatric illness, alcohol or illicit drug dependence, inability to understand study procedures and to comply with them for the entire length of the study, and/or treatment for hypothyroidism, Hypersensitivity to statins or previous use of statins, Use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study, Having tried = 3 prophylactic drugs against migraine during the last 10 years, Consistently failing to respond to any acute migraine medication and/or requiring detoxification from acute medication (triptans, opioids)

研究者

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